In the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects, or PROMOTE, study, researchers at the University of North Texas Health Science Center studied 400 women during their third trimester of pregnancy. Participants were randomly assigned to a usual care plus osteopath manipulative treatment (OMT) group (n=136), a usual care plus placebo ultrasound treatment (PUT) group (n=131), and a usual care only group (n=133). Recruited participants were scheduled to be seen after routine office visits for obstetric care at 30, 32, 34, 36, 37, 38, and 39 weeks of pregnancy. All women in the study were approved for participation by their attending physician, and women with high-risk conditions were excluded.

Both the OMT and PUT were applied over the participants' clothing and focused on the same body areas for 20-minute periods. Body areas treated were bilateral cervical, thoracic, and lumbar paravertebral musculature; thoracolumbar junction; sacroiliac joint; hip; and anterior pelvis. Treatment providers were either certified by the American Osteopathic Board of Neuromusculoskeletal Medicine or board eligible, as well as trained in the PROMOTE protocol. The OMT was applied for 1 to 2 minutes per area until tissue response was observed. For the PUT group, an ultrasound wand was placed on the specified body areas and steady, circular contact was maintained for approximately 2 minutes per area. The ultrasound machine was turned on, and a timer was set, providing credible cues of activity, but no ultrasound waves were emitted. Primary outcome measures were the Roland Morris Disability Questionnaire and characteristic pain intensity on a visual analog scale for “pain now,” “pain average,” “pain best,” and “pain worst.” The results showed significant treatment effects with reduced functional deterioration and pain for both the OMT and PUT groups compared with the usual care only group (P<.001). The effects of OMT were not found to be statistically significantly different than those of PUT. The occurrence of meconium-stained amniotic fluid, a secondary outcome measure, was not found to be different between the 3 groups.

The PROMOTE study is one of the largest randomized controlled trials showing the effectiveness of OMT, and it addressed an important aspect of women's health. I was a treatment provider in this study and can attest to PUT group participants frequently stating that they felt better after ultrasound administration. I agree with the authors' conjecture that this finding appeared related to the patients being touched but also add that this finding could also be related to physician time with the participant in addition to usual prenatal care.